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NICE wants greater access to clinical data

Will turn to European regulators if companies fail to provide information

National Institute for Health and Care Excellence NICE logo 

The UK's National Institute for Heath and Care Excellence (NICE) yesterday announced plans to gain access to more clinical trial data to efficiently assess the cost-effectiveness of new medicines.

NICE, which provides healthcare guidance to the NHS in England and Wales, has updated its technology appraisal process guide, so that now when a pharma company submits a new product for appraisal, its national medical director must declare they have identified all of the product's clinical trial data.

If a pharma company fails to provide the necessary clinical data for NICE to make an informed decision, the watchdog will turn to European regulatory authorities to request access.

To support these changes NICE said it had outlined plans for earlier meetings with companies to discuss decision problems and get advice on the methodology or presentation of clinical trial data.

NICE Prof David HaslamThe announcement comes a week after NICE's chair Prof David Haslam (pictured right) told a House of Commons health select committee that pharma companies had a “moral imperative” to publish all trial data.

“I think everything should be in the public domain and I've always felt that way very strongly.”

Prof Haslam's colleague Prof Carole Longson, who is director for the Health Technology Evaluation Centre at NICE, said Prof Haslam's views were reflected by the organisation.

“We strongly believe that all clinical trial data should be made available so that those with responsibility for developing guidance and making treatment decisions have all the necessary information to hand to help them do so safely and efficiently” said Prof Longson.

NICE has previously declared its support to greater transparency in clinical trial data by signing up to the AllTrials campaign, which calls for all past and present clinical trials to be registered and their full methods and summary results reported.

Several pharma companies, such as GlaxoSmithKlinePfizer and Johnson & Johnson, have announced changes to their data sharing policies as a result of this pressure, while the European Medicines Agency (EMA) is also finalising plans to make it easier for independent researcher to access clinical study reports.

Earlier this month a survey conducted by the Faculty of Pharmaceutical Medicine demonstrated that 81% of pharmaceutical doctors thought that clinical trial sponsors had a “moral duty” to make data available.

Responding to NICE's announcement, the Association of the British Pharmaceutical Indsutry's (ABPI) director of value and access, Paul Catchpole, said the organisation supported the decision.

“It is welcome that NICE have recognised that pharmaceutical companies are the primary source of clinical trial information in the first instance and that companies should have a direct relationship with NICE in this regard," said Catchpole. "We believe that it is appropriate that NICE should only approach the European regulatory authorities if the pharmaceutical companies are unable to provide the requested information.
He added: “The ABPI is committed to greater clinical trial transparency: we believe that clinical trial results should be posted in publicly accessible registries/databases and published in the scientific literature in a timely manner."

Article by
Thomas Meek

10th September 2014

From: Research, Sales, Regulatory, Healthcare



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